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FDA 510(k)

I.B.S. osteosynthesis screws

K-Number: K170594 · 2017-05-10

ApplicantIn2bones Sas
Decision Date2017-05-10
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

I.B.S. osteosynthesis screws is a medical device manufactured by In2bones Sas. It received FDA 510(k) clearance on 2017-05-10 under approval number K170594. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I.B.S. osteosynthesis screws?

I.B.S. osteosynthesis screws is a medical device that received FDA 510(k) clearance on 2017-05-10. It is manufactured by In2bones Sas. The 510(k) number is K170594.

When was I.B.S. osteosynthesis screws approved by the FDA?

I.B.S. osteosynthesis screws received FDA 510(k) clearance on 2017-05-10, under approval number K170594.

What company makes I.B.S. osteosynthesis screws?

I.B.S. osteosynthesis screws is manufactured by In2bones Sas.

What is the FDA product code for I.B.S. osteosynthesis screws?

The FDA product code for I.B.S. osteosynthesis screws is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

NCT06688851 Patient Specific Implants (PSIs) for the Decompression of Odontogenic Cysts RECRUITING

Other Devices by In2bones Sas

K160174I.B.S. 2.0 Osteosynthesis screw K160995NEOVIEW Plating System K153770OS2(R)-VP Varisation Staple K153395OS2-C Compression Staple K153204In2Bones Kirschner wire K170688PIT’Stop® implant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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